Requirements
Advise the business on our expanding line of product offerings as it relates to product claims, ingredients, labels, off-label content, and other applicable matters.
Provide guidance and advice on marketing and advertising of our products, including health claims, in adherence with FTC policy and congruent with NAD/BBB case decisions.
Requirements
Minimum of 10 years experience in Regulatory Affairs in a GMP (Good Manufacturing Practices) environment (medical devices, natural health products/ dietary supplements/pharmaceuticals).
Minimum B.Sc. in pharmaceutical, nutritional, or life sciences or a related scientific field.
Experience in attaining and adhering to compliance with FDA regulations, including 21 CFR 111 (including Subpart L) and FSMA.
Strong knowledge of the FDA regulatory landscape and enforcement discretion trends for dietary supplements and previous experience in managing regulatory activities within the dietary supplement industry.
Strong expertise in interpreting and applying FTC regulatory frameworks, including health claims guidance, 16 CFR Part 260, 16 CFR Part 255—as well as relevant enforcement trends and case law
Strong knowledge of pharmacovigilance activities and risk management activities in relation to dietary supplements.
Previous experience with Proposition 65 compliance and safeguarding.
Previous experience in Complaint Handling and evaluation of Adverse Events/Incidents for reportability to regulatory agencies, including MedWatch (when mandated).
Highly organized with strong attention to detail.
Ability to identify compliance risks and escalate when necessary.
Ability to work and achieve success in an ever-changing, technology-forward fast-paced environment.
Additionally, we'd like to see:
Experience working with live microbials / probiotic products, including manufacturing (CMC), analysis / methodologies, stability, taxonomy, delivery methods, mechanisms of action, and various health outcomes
Experience in working through litigation matters.
Experience in working through a response to a complaint filed through the NAD/BBB.
Experience managing 483s and FDA warning letters
Experience resolving consumer watchdog challenges
Experience in international regulations, including EU, CAN (PLA and NPN registrations for Natural Health Products) and AUS, amongst other jurisdictions.